Satraplatin and Vinorelbine in Advanced Solid Tumors

Sponsor
Southern Europe New Drug Organization
Study ID
NCT01220284
Phase
PHASE1
Status
Unknown

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Satraplatin in combo with vinorelbine — DRUG
    * Satraplatin (gelatin capsules) p.o. on days 1 to 5 (from 60 mg/m2 up to 80 mg/m2) * Vinorelbine (soft capsules) p.o. on days 1, 8 and 15 (from 60 mg/m2 up to 80 mg/m2) The treatment is repeated every 4 weeks.

Study Details

Vinorelbine (NVB) and platinum compounds are anticancer agents with broad spectrum of efficacy, clinically and preclinically proven synergism and only partially overlapping toxicities. Combinations with vinorelbine and platinum compounds with limited neurotoxicity are among the most used palliative regimens in a variety of solid tumors, including NSCLC, breast and cervical cancer. The oral platinum analogue satraplatin (SATRA) has been brought into clinical development because of the antitumor activity and toxicity comparable to those of carboplatin, together with a good acceptability of the oral administration.The recent availability of oral formulation of anticancer agents of proven efficacy in some indications is likely to become a valid option which could affect clinical daily management. The oral administration of vinorelbine and satraplatin might represent a reasonable option of palliative treatment in patients with advanced breast cancer, NSCL, GU or GY tumors for which a curative treatment can not be provided.

Key Dates

Start date
Feb 29, 2008
Status verified
Sep 2010
Primary completion
Nov 30, 2010
Completion
Feb 28, 2011

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Satraplatin in combo with vinorelbine
    Escalating doses of satraplatin and oral vinorelbine in subsequent cohorts of 3-6 patients according to the type and severity grade of acute toxicities observed during cycle 1. The dose escalation process will be discontinued once the MTD is achieved.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) based upon study drug related dose limiting toxicities (DLTs) [ Time Frame: 28 days ]

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